A Multi-Center Study Evaluating the Safety of AC-170 0.24%

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).

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Detailed Description

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Conditions

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Atopic Disease (Including Allergic Conjunctivitis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AC-170 0.24%

Group Type EXPERIMENTAL

Drug: AC-170 0.24%

Intervention Type DRUG

AC-170 0%

Group Type PLACEBO_COMPARATOR

AC-170 0%

Intervention Type DRUG

Interventions

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Drug: AC-170 0.24%

Intervention Type DRUG

AC-170 0%

Intervention Type DRUG

Other Intervention Names

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1 drop in each eye 2 times daily for up to 6 weeks 1 drop in each eye 2 times daily for up to 6 weeks

Eligibility Criteria

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Inclusion Criteria

* at least 2 years of age
* be able to self-administer eye drops or have a parent/legal guardian available for this purpose
* if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
* have ocular health within normal limits

Exclusion Criteria

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No